MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number DM3500

Device Problems Signal Artifact/Noise (1036); Under-Sensing (1661); Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the insertable cardiac monitor exhibited ventricular undersensing.Programming changes were made.The patient was stable.

Event Description

Additional information received noted the insertable cardiac monitor continued to exhibit undersensing after the previous programming changes were made.No additional changes were made.The patient was stable and will be monitored.

Manufacturer Narrative

Additional information: b5, h6.

Event Description

Additional information received noted the patient presented remotely via merln.Net.Upon investigation, the insertable cardiac monitor was found undersensing during a symptomatic event.R-waves were confirmed.Noise was attributed to displacement/positional changes.No changes were made.Endless transmissions of false pauses were noted.No other patient symptoms were reported.

• Brand Name: CONFIRM
• Type of Device: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10662969
• MDR Text Key: 211034111
• Report Number: 2017865-2020-15243
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067027320
• UDI-Public: 05415067027320
• Combination Product (y/n): N
• PMA/PMN Number: K163407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2022
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: P000106997
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR